FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T97-57                      Marian Segal:        301-827-6242
Nov. 24, 1997               
                            Consumer Inquiries:  800-532-4440


            FDA APPROVES SIBUTRAMINE TO TREAT OBESITY

     FDA has approved sibutramine (Meridia) for the management of
obesity, a widespread, chronic disease that, combined with other
risk factors contributes to the deaths of an estimated 300,000
Americans each year.  Marketing is pending scheduling by the U.S.
Drug Enforcement Administration.  The following can be used to
answer questions:
     Sibutramine helps reduce food intake and is indicated for
weight loss and maintenance of weight loss when used in
conjunction with a reduced calorie diet.  It is indicated for
people whose initial body mass index (BMI) is at least 30 -- that
is, someone who is 5'6" and weighs 185 lbs. or more.  Patients
with other risk factors, such as hypertension or diabetes, can be
treated with the drug if their BMI is 27 or higher, for example
someone who is 5'6" and weighs 167 lbs. or more.
     Sibutramine works to suppress the appetite primarily by
inhibiting the reuptake of the neurotransmitters norepinephrine
and serotonin.  The anti-obesity drug dexfenfluramine also
inhibits the reuptake of serotonin.  However, dexfenfluramine, 
unlike sibutramine, also causes an increase in release of
serotonin from the nerve cell.
     In clinical trials, patients treated with sibutramine while
on a reduced-calorie diet, showed a significant weight loss
during the first six months of treatment, and significant weight
loss was maintained for one year.  In one 12-month study, the
average weight loss in patients taking sibutramine, 10 mg daily,
was about 10 lbs., and in those taking 15 mg daily was about 14
lbs.  The average weight loss in persons on only a reduced
calorie diet was 3.5 lbs.
     The most common side effects associated with sibutramine
include dry mouth, headache, constipation and insomnia.  The drug
causes a small increase in average blood pressure, and causes a
higher increase in some patients.  FDA recommends patients taking
sibutramine have regular blood pressure evaluations.  People with
uncontrolled high blood pressure should not take sibutramine.     
No cases of pulmonary hypertension, a rare but serious side
effect associated with the anti-obesity drugs fenfluramine and
dexfenfluramine, have been reported in clinical trials of
sibutramine.  Echocardiograms on patients taking sibutramine did
not show more valvular disease than those on placebo.
     Sibutramine is manufactured and distributed by Knoll
Pharmaceutical Company, Mount Olive, NJ, under the brand name
Meridia.
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